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Executive Summary: End-To-End Regulatory CDMO Solutions: Development, Manufacturing, and Approval
July 25th 2025The road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.
Core2Scan® System: Precise Asset Management for Regulated Industries
May 29th 2025Created specifically for the pharma biotech industry by Veltek Associates, Core2Scan is the tracking, asset management, and process improvement solution that boosts bottom lines and so much more. Powered by RFID, Core2Scan keeps tabs on any onsite physical asset your organization wants to track. Better yet, its invaluable data can drive smarter processes and savings throughout your entire G-M-P facility.
HME vs Spray Drying: A Comparison of Saturated Solubility Enhancement
May 29th 2025Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.
Analytical tools & techniques in Hot Melt Extrusion
May 29th 2025Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.
Photometer Calibration: Calibration Error Due to Errors in Gravimetric Standard of Measurement
May 28th 2025This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.